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Licensed 4CMenB vaccine
4CMenB is a recombinant meningococcal serogroup B vaccine that stimulates the immune system to produce antibodies against Neisseria meningitidis serogroup B.
4CMenB is a recombinant meningococcal serogroup B vaccine that stimulates the immune system to produce antibodies against Neisseria meningitidis serogroup B. Used for Prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B.
At a glance
| Generic name | Licensed 4CMenB vaccine |
|---|---|
| Also known as | Bexsero® |
| Sponsor | University of Adelaide |
| Drug class | Recombinant protein vaccine |
| Target | Neisseria meningitidis serogroup B surface antigens |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
The vaccine contains recombinant proteins from the meningococcal serogroup B capsule and outer membrane, which are presented to the immune system to generate both humoral (antibody) and cellular immune responses. This allows the body to recognize and neutralize the pathogen upon natural exposure, preventing invasive meningococcal disease caused by serogroup B strains.
Approved indications
- Prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B
Common side effects
- Injection site pain/erythema
- Fever
- Myalgia
- Fatigue
- Headache
Key clinical trials
- Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants (PHASE1, PHASE2)
- Study of a Novel Multicomponent Meningococcal Group B Vaccine When Given Alone or With Other Licensed Vaccines in Adults, Adolescents, Toddlers and Infants (PHASE1)
- Study to Evaluate the Immune Response After a Booster Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine When Administered Alone or Concomitantly With a Licensed Meningococcal Serogroup B Vaccine, in Participants Who Received Primary Quadrivalent Meningococcal Conjugate Vaccine (MCV4) (PHASE3)
- Investigating Meningococcal Vaccines in Adults (NA)
- Investigating the Immunogenicity of a U.S.-Licensed Meningococcal Serogroup B Vaccine (Trumenba) (PHASE4)
- A Pilot Clinical Study of PET Scanning in Evaluation of Vaccine Reactogenicity (NA)
- South Australian Meningococcal B Vaccine Herd Immunity Study (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Licensed 4CMenB vaccine CI brief — competitive landscape report
- Licensed 4CMenB vaccine updates RSS · CI watch RSS
- University of Adelaide portfolio CI